AMS SLING FIXATION SYSTEM
Device Facts
| Record ID | K010990 |
|---|---|
| Device Name | AMS SLING FIXATION SYSTEM |
| Applicant | American Medical Systems, Inc. |
| Product Code | GAW · General, Plastic Surgery |
| Decision Date | Jun 22, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5010 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
